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Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

Primary Purpose

Full-thickness Rotator Cuff Tear, Rotator Cuff Tendinitis

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Marcaine
Kenalog
Sponsored by
Michael Khazzam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full-thickness Rotator Cuff Tear focused on measuring Shoulder, Rotator Cuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: > or = 18 years old
  • Rotator Cuff Tendinitis
  • Atraumatic Full-thickness Rotator Cuff Tear
  • Subjects who speak English
  • Women who are of non-childbearing potential

Exclusion Criteria:

  • Age: < 18 years old
  • Prior Shoulder Surgery
  • Fracture
  • Acute Traumatic Rotator Cuff Tear
  • Infection
  • Uncontrolled Diabetes Mellitus (HbA1c >8)
  • Uncontrolled High Blood Pressure (Hypertension)
  • Recent Prior Shoulder Injection in either the Subacromial space Workers Compensation
  • History of Peptic Ulcer disease (includes both Gastric and Duodenal Ulcers), Gastrointestinal perforation, Inflammatory Bowel disease (Ulcerative Colitis, Crohn's disease), or any other gastrointestinal pathology
  • Tumor Involving the Shoulder Region
  • Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias
  • Subject unable to provide informed consent
  • Subjects who don't speak English
  • Patients who are pregnant or lactating at time of screening or are of pregnant bearing age
  • Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
  • Patients taking any anti-platelet agents, warfarin or other anticoagulants, or SSRIs.
  • Patients with any bleeding disorders such as coagulopathy, hypercoagulable state, or platelet disorders including thrombocytopenia.
  • Patients with cardiac disease such as congestive heart failure, coronary artery disease, or myocardial infarction.
  • Patients with severe renal failure. Patients with severe liver impairment or active liver disease.
  • Patients with heavy alcohol use; this is defined as consuming 8 or more drinks per week for a woman and 15 or more drinks per week for a man.
  • Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations. Patients with a known hypersensitivity to bupivacaine or other local anesthetic agent of the amide-type.
  • Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
  • Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs.
  • Patients who are currently on probenecid or pentoxifylline as described in the approved label of Ketorolac tromethamine injection.

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Other

Arm Label

Group 1 (marcaine)

Group 2 (ketorolac)

Group 3 (kenalog)

Arm Description

will receive an injection of 4 cc 0.25% Marcaine without epinephrine

will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1

4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1. Group 3 is standard of care

Outcomes

Primary Outcome Measures

Visual Analog Scale
Pain as measured by the Visual Analog Scale prior to first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale after first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Visual Analog Scale
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
American Shoulder and Elbow Score (ASES)
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
American Shoulder and Elbow Score (ASES)
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
American Shoulder and Elbow Score (ASES)
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.

Secondary Outcome Measures

Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)

Full Information

First Posted
May 12, 2021
Last Updated
January 12, 2023
Sponsor
Michael Khazzam
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1. Study Identification

Unique Protocol Identification Number
NCT04895280
Brief Title
Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections
Official Title
Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Khazzam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid. Specific Aim 1: Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies. The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.
Detailed Description
The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this study investigators will compare the effectiveness of ketorolac compared to corticosteroid. Subjects being seen for a rotator cuff injury will be randomized into one of three treatment groups pertaining to their pathology. The intervention will begin once the subject has consented and answered the Baseline Outcome Shoulder Questionnaire. The Baseline Outcome Questionnaire consists of the Visual Analog Score, American Shoulder and Elbow Score, Single Assessment Numeric Evaluation, Pittsburgh Sleep Quality Index, Short Form-12, and questions pertaining to patient characteristics, injury characteristics, co-morbidities, patient history, medications, and demographics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full-thickness Rotator Cuff Tear, Rotator Cuff Tendinitis
Keywords
Shoulder, Rotator Cuff

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (marcaine)
Arm Type
Other
Arm Description
will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Arm Title
Group 2 (ketorolac)
Arm Type
Experimental
Arm Description
will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1
Arm Title
Group 3 (kenalog)
Arm Type
Other
Arm Description
4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1. Group 3 is standard of care
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1
Intervention Type
Drug
Intervention Name(s)
Marcaine
Other Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Intervention Type
Drug
Intervention Name(s)
Kenalog
Other Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
Kenalog: 4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale prior to first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Baseline - pre-injection
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale after first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Baseline - immediately after the injection
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Day 2
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Week 1
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Week 2
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Week 4
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Week 6
Title
Visual Analog Scale
Description
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Time Frame
Week 12
Title
American Shoulder and Elbow Score (ASES)
Description
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Time Frame
Baseline
Title
American Shoulder and Elbow Score (ASES)
Description
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Time Frame
Week 6
Title
American Shoulder and Elbow Score (ASES)
Description
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Single Assessment Numeric Evaluation (SANE)
Description
Measure the patient's self-reported function on a scale of 0 to 100
Time Frame
Baseline
Title
Single Assessment Numeric Evaluation (SANE)
Description
Measure the patient's self-reported function on a scale of 0 to 100
Time Frame
Week 6
Title
Single Assessment Numeric Evaluation (SANE)
Description
Measure the patient's self-reported function on a scale of 0 to 100
Time Frame
Week 12
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time Frame
Week 6
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time Frame
Week 12
Title
Short Form 12 (SF-12)
Description
General health survey as measured by the Short Form 12 (SF-12)
Time Frame
Baseline
Title
Short Form 12 (SF-12)
Description
General health survey as measured by the Short Form 12 (SF-12)
Time Frame
Week 6
Title
Short Form 12 (SF-12)
Description
General health survey as measured by the Short Form 12 (SF-12)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: > or = 18 years old Rotator Cuff Tendinitis Atraumatic Full-thickness Rotator Cuff Tear Subjects who speak English Women who are of non-childbearing potential Exclusion Criteria: Age: < 18 years old Prior Shoulder Surgery Fracture Acute Traumatic Rotator Cuff Tear Infection Uncontrolled Diabetes Mellitus (HbA1c >8) Uncontrolled High Blood Pressure (Hypertension) Recent Prior Shoulder Injection in either the Subacromial space Workers Compensation History of Peptic Ulcer disease (includes both Gastric and Duodenal Ulcers), Gastrointestinal perforation, Inflammatory Bowel disease (Ulcerative Colitis, Crohn's disease), or any other gastrointestinal pathology Tumor Involving the Shoulder Region Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias Subject unable to provide informed consent Subjects who don't speak English Patients who are pregnant or lactating at time of screening or are of pregnant bearing age Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response. Patients taking any anti-platelet agents, warfarin or other anticoagulants, or SSRIs. Patients with any bleeding disorders such as coagulopathy, hypercoagulable state, or platelet disorders including thrombocytopenia. Patients with cardiac disease such as congestive heart failure, coronary artery disease, or myocardial infarction. Patients with severe renal failure. Patients with severe liver impairment or active liver disease. Patients with heavy alcohol use; this is defined as consuming 8 or more drinks per week for a woman and 15 or more drinks per week for a man. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations. Patients with a known hypersensitivity to bupivacaine or other local anesthetic agent of the amide-type. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs. Patients who are currently on probenecid or pentoxifylline as described in the approved label of Ketorolac tromethamine injection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Wright
Phone
214-645-0423
Email
Cynthia.Wright@UTSouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Khazzam, MD
Phone
214-645-3300
Email
Michael.Khazzam@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Khazzam, MD
Organizational Affiliation
214-645-3300
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Wright
Phone
214-645-0423
Email
Cynthia.Wright@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Josseline Lopez
Phone
214-645-1620
Email
Josseline.Lopez@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Michael Khazzam, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

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